EP 1993557 B1 20151111 - NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF
Title (en)
NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF
Title (de)
NEUARTIGE EPOPROSTENOLFORMULIERUNG UND HERSTELLUNGSVERFAHREN DAFÜR
Title (fr)
NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION
Publication
Application
Priority
- US 2007002948 W 20070202
- US 76476906 P 20060203
- US 77256306 P 20060213
- US 78342906 P 20060320
Abstract (en)
[origin: WO2007092343A2] This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30<SUP>o</SUP>C for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH > 11. Methods for making the lyophilized composition are also disclosed.
IPC 8 full level
A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 31/557 (2006.01); A61K 31/5585 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2006.01); A61K 47/26 (2006.01)
CPC (source: EP KR US)
A61K 9/0019 (2013.01 - EP US); A61K 9/19 (2013.01 - EP US); A61K 31/557 (2013.01 - EP KR US); A61K 31/5585 (2013.01 - EP KR US); A61K 47/183 (2013.01 - EP US); A61K 47/26 (2013.01 - EP US); A61P 9/00 (2017.12 - EP); A61P 9/04 (2017.12 - EP); A61P 9/10 (2017.12 - EP); A61P 9/12 (2017.12 - EP)
Citation (opposition)
Opponent : GENERICS (U.K.) LIMITED
- US 2013018093 A1 20130117 - PALEPU NAGESH [US]
- GB 2021581 A 19791205 - WELLCOME FOUND
- EP 0005768 A1 19791212 - WELLCOME FOUND [GB]
- US 2005226893 A1 20051013 - JUNEAU JENNIFER [US], et al
- X. TANG ET AL.: "Design of Freeze-Drying Process for Pharmaceuticals: Practical Advice", PHARMACEUTICAL RESEARCH, vol. 21, no. 2, 2004, pages 191 - 200, XP055305721
- D.W.A. SHARP, PENGUIN DICTIONARY OF CHEMISTRY., 1990
- "GLAXOSMITHKLINE, RESEARCH TRIANGLE PARK, NC", PRESCRIBING INFORMATION FLOLAN (EPOPROSTENOL SODIUM, September 2002 (2002-09-01), pages 1 - 24
Designated contracting state (EPC)
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR
DOCDB simple family (publication)
WO 2007092343 A2 20070816; WO 2007092343 A3 20080117; BR PI0707488 A2 20110503; BR PI0707488 B1 20200526; BR PI0707488 B8 20210525; CA 2641393 A1 20070816; CA 2641393 C 20141216; CA 2868998 A1 20070816; CN 101410119 A 20090415; CN 101410119 B 20120307; DK 1993557 T3 20151207; EP 1993557 A2 20081126; EP 1993557 A4 20120725; EP 1993557 B1 20151111; ES 2558705 T3 20160208; HU E026166 T2 20160530; JP 2009525344 A 20090709; JP 5415771 B2 20140212; KR 101351668 B1 20140114; KR 20090004867 A 20090112; PL 1993557 T3 20160531; PT 1993557 E 20160210; SI 1993557 T1 20160129; US 2009088468 A1 20090402; US 2013018093 A1 20130117; US 8318802 B2 20121127; US 8598227 B2 20131203
DOCDB simple family (application)
US 2007002948 W 20070202; BR PI0707488 A 20070202; CA 2641393 A 20070202; CA 2868998 A 20070202; CN 200780011395 A 20070202; DK 07763188 T 20070202; EP 07763188 A 20070202; ES 07763188 T 20070202; HU E07763188 A 20070202; JP 2008553381 A 20070202; KR 20087021569 A 20070202; PL 07763188 T 20070202; PT 07763188 T 20070202; SI 200731721 T 20070202; US 201213621489 A 20120917; US 27806107 A 20070202